Eight medicines leap towards EU approval

Eight medicines – including two biosimilars – have taken a giant step towards being approved for the European market having won favour with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Approval of Pfizer’s oral Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has been recommended as a treatment for rheumatoid arthritis (RA).

According to the Committee, the drug’s benefits are its ability to reduce the signs and symptoms of RA and to improve physical function, and also has the potential to slow the progression of joint damage in patients with the condition.

Back in 2013 the drug was not recommended by CHMP for RA, on grounds that it “did not believe that a consistent reduction in disease activity and structural damage to joints had been sufficiently demonstrated”.

Therakind’s hybrid medicine Jylamvo (methotrexate), the application for which is based in part on the results of preclinical tests, clinical trials for a reference product, and new data – has received a positive opinion for the treatment of rheumatological disorders and psoriasis, and for the maintenance treatment of acute lymphoblastic leukaemia (ALL).

The drug can reduce the symptoms of rheumatoid arthritis, severe juvenile idiopathic arthritis, psoriasis and psoriatic arthritis, and exert a sustained effect on malignant growth in ALL, the CHMP noted.

Two biosimilars medicines were put forward for approval by the Committee: Amgen’s Amgevita and Solymbic, both of which contain adalimumab, the active ingredient in AbbVie’s mega blockbuster Humira.

The positive CHMP opinion “marks the first time an adalimumab biosimilar has been recommended for approval in the EU,” noted Sean Harper, executive vice president of R&D at Amgen, adding that it “represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”

Amgevita is targeting the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.

Solymbic is intended for the treatment of rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis.

Also winning CHMP favour were: GlaxoSmithKline’s Rolufta(umeclidinium) for the treatment of chronic obstructive pulmonary disease; Lilly’s Tadalafil Lilly (tadalafil) for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia; JensonR+‘s Yargesa (miglustat) for the treatment of Gaucher disease; and Hospira UK’s Daptomycin Hospira (daptomycin) for the treatment of complicated skin and soft-tissue infections (cSSTI), right-sided infective endocarditis (RIE) due to Staphylococcus aureus and S. aureus bacteraemia associated with RIE or with cSSTI.

Source:pharmatimes.com

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